Current Advances in Clinical Trials for Rare Disease Populations: Spotlight on the Patient
Curr Clin Pharmacol. 2021 Mar 16. doi: 10.2174/1574884716666210316120615. Online ahead of print.ABSTRACTCharacterized by small, highly heterogeneous patient populations, rare disease trials magnify the challenges often encountered in traditional clinical trials. In recent years, there have been increased efforts by stakeholders to improve drug development in rare diseases through novel approaches to clinical trial designs and statistical analyses. We highlight and discuss some of the current and emerging approaches aimed at overcoming challenges in rare disease clinical trials, with a focus on the ultimate stakeholder, the...
Source: Current Clinical Pharmacology - March 17, 2021 Category: Drugs & Pharmacology Authors: Erica Winter Scott Schliebner Source Type: research
Is it possible to estimate the bioequivalence between parenteral and enteral formulations of escin?
Curr Clin Pharmacol. 2021 Mar 8. doi: 10.2174/1574884716666210309103109. Online ahead of print.ABSTRACTWe suggest that enteral formulation of escin could be used instead of enteral formulation, if it is not available.PMID:33687899 | DOI:10.2174/1574884716666210309103109 (Source: Current Clinical Pharmacology)
Source: Current Clinical Pharmacology - March 10, 2021 Category: Drugs & Pharmacology Authors: Luca Gallelli Erika Cione Leiming Zhang Wang Tian Source Type: research
Predictability of Elimination and Excretion of Small Molecules from Animals to Humans, and Impact on Dosimetry for human ADME Studies with Radiolabeled Drugs
CONCLUSION: In all cases where the plasma elimination half-life for 14C in humans was found to be longer than the predicted value, the radiation burden was still within ICRP Category IIa. Containment of the actual radiation burden below the limit of 1.00 mSv appeared to be determined partly also by our choice to limit 14C doses to 3.7 MBq.PMID:33687900 | DOI:10.2174/1574884716666210309103625 (Source: Current Clinical Pharmacology)
Source: Current Clinical Pharmacology - March 10, 2021 Category: Drugs & Pharmacology Authors: Ad Roffel Jan Jaap van Lier Gerk Rozema Ewoud-Jan van Hoogdalem Source Type: research
Is it possible to estimate the bioequivalence between parenteral and enteral formulations of escin?
Curr Clin Pharmacol. 2021 Mar 8. doi: 10.2174/1574884716666210309103109. Online ahead of print.ABSTRACTWe suggest that enteral formulation of escin could be used instead of enteral formulation, if it is not available.PMID:33687899 | DOI:10.2174/1574884716666210309103109 (Source: Current Clinical Pharmacology)
Source: Current Clinical Pharmacology - March 10, 2021 Category: Drugs & Pharmacology Authors: Luca Gallelli Erika Cione Leiming Zhang Wang Tian Source Type: research
Predictability of Elimination and Excretion of Small Molecules from Animals to Humans, and Impact on Dosimetry for human ADME Studies with Radiolabeled Drugs
CONCLUSION: In all cases where the plasma elimination half-life for 14C in humans was found to be longer than the predicted value, the radiation burden was still within ICRP Category IIa. Containment of the actual radiation burden below the limit of 1.00 mSv appeared to be determined partly also by our choice to limit 14C doses to 3.7 MBq.PMID:33687900 | DOI:10.2174/1574884716666210309103625 (Source: Current Clinical Pharmacology)
Source: Current Clinical Pharmacology - March 10, 2021 Category: Drugs & Pharmacology Authors: Ad Roffel Jan Jaap van Lier Gerk Rozema Ewoud-Jan van Hoogdalem Source Type: research
Is it possible to estimate the bioequivalence between parenteral and enteral formulations of escin?
Curr Clin Pharmacol. 2021 Mar 8. doi: 10.2174/1574884716666210309103109. Online ahead of print.ABSTRACTWe suggest that enteral formulation of escin could be used instead of enteral formulation, if it is not available.PMID:33687899 | DOI:10.2174/1574884716666210309103109 (Source: Current Clinical Pharmacology)
Source: Current Clinical Pharmacology - March 10, 2021 Category: Drugs & Pharmacology Authors: Luca Gallelli Erika Cione Leiming Zhang Wang Tian Source Type: research
Predictability of Elimination and Excretion of Small Molecules from Animals to Humans, and Impact on Dosimetry for human ADME Studies with Radiolabeled Drugs
CONCLUSION: In all cases where the plasma elimination half-life for 14C in humans was found to be longer than the predicted value, the radiation burden was still within ICRP Category IIa. Containment of the actual radiation burden below the limit of 1.00 mSv appeared to be determined partly also by our choice to limit 14C doses to 3.7 MBq.PMID:33687900 | DOI:10.2174/1574884716666210309103625 (Source: Current Clinical Pharmacology)
Source: Current Clinical Pharmacology - March 10, 2021 Category: Drugs & Pharmacology Authors: Ad Roffel Jan Jaap van Lier Gerk Rozema Ewoud-Jan van Hoogdalem Source Type: research
Is it possible to estimate the bioequivalence between parenteral and enteral formulations of escin?
Curr Clin Pharmacol. 2021 Mar 8. doi: 10.2174/1574884716666210309103109. Online ahead of print.ABSTRACTWe suggest that enteral formulation of escin could be used instead of enteral formulation, if it is not available.PMID:33687899 | DOI:10.2174/1574884716666210309103109 (Source: Current Clinical Pharmacology)
Source: Current Clinical Pharmacology - March 10, 2021 Category: Drugs & Pharmacology Authors: Luca Gallelli Erika Cione Leiming Zhang Wang Tian Source Type: research
Predictability of Elimination and Excretion of Small Molecules from Animals to Humans, and Impact on Dosimetry for human ADME Studies with Radiolabeled Drugs
CONCLUSION: In all cases where the plasma elimination half-life for 14C in humans was found to be longer than the predicted value, the radiation burden was still within ICRP Category IIa. Containment of the actual radiation burden below the limit of 1.00 mSv appeared to be determined partly also by our choice to limit 14C doses to 3.7 MBq.PMID:33687900 | DOI:10.2174/1574884716666210309103625 (Source: Current Clinical Pharmacology)
Source: Current Clinical Pharmacology - March 10, 2021 Category: Drugs & Pharmacology Authors: Ad Roffel Jan Jaap van Lier Gerk Rozema Ewoud-Jan van Hoogdalem Source Type: research
Is it possible to estimate the bioequivalence between parenteral and enteral formulations of escin?
Curr Clin Pharmacol. 2021 Mar 8. doi: 10.2174/1574884716666210309103109. Online ahead of print.ABSTRACTWe suggest that enteral formulation of escin could be used instead of enteral formulation, if it is not available.PMID:33687899 | DOI:10.2174/1574884716666210309103109 (Source: Current Clinical Pharmacology)
Source: Current Clinical Pharmacology - March 10, 2021 Category: Drugs & Pharmacology Authors: Luca Gallelli Erika Cione Leiming Zhang Wang Tian Source Type: research
Predictability of Elimination and Excretion of Small Molecules from Animals to Humans, and Impact on Dosimetry for human ADME Studies with Radiolabeled Drugs
CONCLUSION: In all cases where the plasma elimination half-life for 14C in humans was found to be longer than the predicted value, the radiation burden was still within ICRP Category IIa. Containment of the actual radiation burden below the limit of 1.00 mSv appeared to be determined partly also by our choice to limit 14C doses to 3.7 MBq.PMID:33687900 | DOI:10.2174/1574884716666210309103625 (Source: Current Clinical Pharmacology)
Source: Current Clinical Pharmacology - March 10, 2021 Category: Drugs & Pharmacology Authors: Ad Roffel Jan Jaap van Lier Gerk Rozema Ewoud-Jan van Hoogdalem Source Type: research
Ventilatory Response to Hypercapnia as Experimental Model to Study Effects of Oxycodone on Respiratory Depression
CONCLUSIONS: This model for testing ventilatory response to hypercapnia discriminated the effect of 30 mg of oxycodone vs. placebo for up to 3 hours after a single dose. It may serve as a method to predict the relative effect of a drug on respiratory depression.PMID:33632110 | DOI:10.2174/1574884716666210225083213 (Source: Current Clinical Pharmacology)
Source: Current Clinical Pharmacology - February 26, 2021 Category: Drugs & Pharmacology Authors: Lynn R Webster Erik Hansen Gregory J Stoddard Austin Rynders David Ostler Harley Lennon Source Type: research
Ventilatory Response to Hypercapnia as Experimental Model to Study Effects of Oxycodone on Respiratory Depression
CONCLUSIONS: This model for testing ventilatory response to hypercapnia discriminated the effect of 30 mg of oxycodone vs. placebo for up to 3 hours after a single dose. It may serve as a method to predict the relative effect of a drug on respiratory depression.PMID:33632110 | DOI:10.2174/1574884716666210225083213 (Source: Current Clinical Pharmacology)
Source: Current Clinical Pharmacology - February 26, 2021 Category: Drugs & Pharmacology Authors: Lynn R Webster Erik Hansen Gregory J Stoddard Austin Rynders David Ostler Harley Lennon Source Type: research
Ventilatory Response to Hypercapnia as Experimental Model to Study Effects of Oxycodone on Respiratory Depression
CONCLUSIONS: This model for testing ventilatory response to hypercapnia discriminated the effect of 30 mg of oxycodone vs. placebo for up to 3 hours after a single dose. It may serve as a method to predict the relative effect of a drug on respiratory depression.PMID:33632110 | DOI:10.2174/1574884716666210225083213 (Source: Current Clinical Pharmacology)
Source: Current Clinical Pharmacology - February 26, 2021 Category: Drugs & Pharmacology Authors: Lynn R Webster Erik Hansen Gregory J Stoddard Austin Rynders David Ostler Harley Lennon Source Type: research
Ventilatory Response to Hypercapnia as Experimental Model to Study Effects of Oxycodone on Respiratory Depression
CONCLUSIONS: This model for testing ventilatory response to hypercapnia discriminated the effect of 30 mg of oxycodone vs. placebo for up to 3 hours after a single dose. It may serve as a method to predict the relative effect of a drug on respiratory depression.PMID:33632110 | DOI:10.2174/1574884716666210225083213 (Source: Current Clinical Pharmacology)
Source: Current Clinical Pharmacology - February 26, 2021 Category: Drugs & Pharmacology Authors: Lynn R Webster Erik Hansen Gregory J Stoddard Austin Rynders David Ostler Harley Lennon Source Type: research
